Universal positioning device for orthopedic surgery and method of use thereof

ABSTRACT

A positioning device assembly for positioning a tool guide block for use in an orthopedic surgery includes a positioning device having a block body with a reference surface adapted to abut a bone element, and first and second adjustment mechanisms that are independently operable. The first adjustment mechanism permits rotation of the tool guide block about a medial-lateral extending axis to provide flexion-extension angle adjustment and the second adjustment mechanism permits rotation of the tool guide block about an anterior-posterior extending axis to provide varus-valgus angle adjustment. The second adjustment mechanism includes integral coarse and fine adjustment mechanisms. A tool guide block assembly mounted to the positioning device includes a platform portion which is engaged to the block body of the positioning device and the tool guide block which is releasably engaged with the platform.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 12/626,645 filed Nov. 26, 2009 now U.S. Pat. No. 8,277,455, which isa continuation of International Patent Application No. PCT/CA2008/001272filed Jul. 9, 2008, which claims priority on U.S. Provisional PatentApplication No. 60/948,546 filed Jul. 9, 2007, the entire contents ofall of which are incorporated herein by reference.

TECHNICAL FIELD

The present invention relates generally to a surgical tool assembly andits method of use in orthopedic knee surgery. More particularly, thepresent invention is directed to a multiple degree-of-freedom universalpositioning device assembly, for use with a computer assisted surgery(CAS) system in total knee replacement surgery.

BACKGROUND OF THE ART

Computer Assisted Surgery (CAS) systems are being increasingly used fororthopedic operations in general, and for joint replacement surgeries inparticular, in order to continue to improve the accuracy and long-termsuccess of joint replacement surgery. The accuracy of cuts and drilledholes performed in joint replacement surgeries such as in kneearthroplasty, or total knee replacement, is of prime importance, suchthat the installation of the implants can be made such that they bestduplicate the kinematics of the natural knee.

Known optical, radio frequency and magnetic based CAS systems employpassive and active trackable elements affixed to objects, such assurgical tools and patient bone references, in order to permit thedetermination of position and orientation of the objects inthree-dimensional space. Preoperatively taken images, computer generatedmodels created from preoperative patient scans or intra operativelandmark digitization are some of the methods used to provide accuratepatient anatomical information to the CAS system, such that thereal-time position of the same anatomical elements can be registered orcalibrated and thus tracked by the system, permitting the display to thesurgeon of these elements relative to the surgical tools used during thesurgery.

Total knee replacement surgery, for example, may require one or moreprecise cuts to be made in the femur and/or tibia to completely removethe knee joint, such that the implant may fit correctly and bestreplicates the geometry of a natural healthy knee. To perform thesesteps, in both conventional and CAS total knee replacement surgeries, itis known to use a tool or implement known as a surgical tool guide blockwhich provides a drill and/or cutting guide to assist the surgeon toperform the steps required to prepare the femur and tibia for receivingthe implant. For example, using known CAS surgery techniques, thesurgical tool guide block, such as a saw cutting guide for example,would be drilled or screwed into that part of the bone to be severed,while in other bone CAS systems, and its position would be determinedthrough known methods using the CAS system.

To best permit the desired positioning and fixation of the surgical toolguide block in the determined position, a surgeon typically uses apositioning block which requires controllable adjustment of severaldegrees of freedom.

While certain flexibility is provided by such total knee replacementpositioning blocks of the prior art, there nevertheless remains a needfor an improved positioning device permitting additional control of theadjustment thereof, and being adapted for use with a CAS system.

SUMMARY

It is therefore an object of the invention to provide at least animproved universal positioning device for use in orthopedic surgery.

There is therefore provided, in accordance with one possible aspect, adevice for positioning a tool guide block, said device comprising: apositioning device including a block body having an inwardly facingreference surface adapted to abut a bone element, the positioning deviceincluding a first adjustment mechanism and a second adjustment mechanismindependently operable from the first adjustment mechanism, the firstadjustment mechanism permitting rotation of the tool guide block about amedial-lateral extending axis such as to provide flexion-extension angleadjustment, the second adjustment mechanism permitting rotation of thetool guide block about an anterior-posterior extending axis such as toprovide varus-valgus angle adjustment, the second adjustment mechanismincluding a coarse adjustment mechanism and a fine adjustment mechanism;and a tool guide mounted to the positioning device, the tool guideincluding a platform portion which is engaged to the block body of thepositioning device and the tool guide block which is releasably engagedwith the platform.

There is also provided, in accordance with another aspect, a device foruse in orthopedic knee replacement surgery on a femur, said devicecomprising: a positioning device including a block body having aninwardly facing reference surface adapted to abut a distal end of thefemur, the positioning device including a first adjustment mechanism anda second adjustment mechanism independently operable from the firstadjustment mechanism; a tool guide mounted to the positioning device,the tool guide including a platform portion which is engaged to theblock body of the positioning device and a tool guide block which isreleasably engaged with the platform; and wherein the first adjustmentmechanism permits rotation of the tool guide block about amedial-lateral extending axis such as to provide flexion-extension angleadjustment, the second adjustment mechanism permitting rotation of thetool guide block about an anterior-posterior extending axis such as toprovide varus-valgus angle adjustment, the second adjustment mechanismincluding a coarse adjustment mechanism and a fine adjustment mechanism.

There is additionally provided, in accordance with another aspect, adevice for use in orthopedic knee replacement surgery on a femur, saiddevice comprising: a positioning device including a block body having afirst inwardly facing reference surface adapted to abut a distal end ofthe femur and a second reference surface adapted to abut a posteriorside of the femur, the second reference surface being substantiallyperpendicular to the first reference surface, the positioning devicebeing positionable relative to the femur without being fastened thereto;a tool guide mounted to the positioning device, the tool guide includinga platform portion which is engaged to the block body of the positioningdevice and a tool guide block which is releasably engaged with theplatform via a proximal-distal adjustment mechanism permitting the toolguide block to be displaced relative to the platform, and thus the firstinwardly facing reference surface of the positioning device, in adirection substantially perpendicular to the first reference surface,such as to adjust a distal resection depth in the femur; and avarus-valgus adjustment mechanism independently operable from theproximal-distal adjustment mechanism and provided in the block body ofthe positioning device for adjustment of a varus-valgus angle of theblock body relative to the femur and therefore the varus-valgus angle ofthe tool guide block mounted to the positioning device.

There is further provided, in accordance with another aspect a method ofinstalling a tool guide block on a knee bone element in preparation of acut to be performed in the knee bone element during orthopedic kneereplacement surgery, the tool guide block being engaged to a positioningdevice, the method comprising: abutting a first reference surface of thepositioning device against the knee bone element; determining a desiredposition and orientation of the tool guide block relative to the kneebone element; adjusting at least one of a positioning and orientation ofthe positioning device until the tool guide block engaged thereto is insaid desired position and orientation, the step of adjusting comprising:adjusting a flexion-extension angle of the tool guide block whilemaintaining the first reference surface abutted against the knee boneelement; independently adjusting a varus-valgus angle of the tool guideblock by first making a coarse adjustment and then making a fineadjustment; adjusting a distal resection depth by displacing the toolguide block relative to the positioning device; locking the positioningdevice in position such as to maintain the adjusted flexion-extensionangle, varus-valgus angle, and distal resection depth of the tool guideblock; and fastening the tool guide block in place to the knee boneelement once the desired position and orientation of the tool guideblock has been reached.

BRIEF DESCRIPTION OF THE DRAWINGS

Further features and advantages of the present invention will becomeapparent from the following detailed description, taken in combinationwith the appended drawings, in which:

FIG. 1 is a perspective view of a universal positioning device assemblyin accordance with one aspect of the present invention, shown mounted toa femur, the universal positioning device assembly including apositioning device and a tool guide block assembly engaged thereto;

FIG. 2 is a perspective view of the positioning device of the assemblyof FIG. 1;

FIG. 3 is another perspective view of the positioning device of theassembly of FIG. 1;

FIG. 4 is a perspective view of a locating spike used to fasten thepositioning device to a bone element;

FIG. 5 is a perspective view of a tool guide block assembly which mountsto the positioning device of FIG. 3;

FIG. 6 is a perspective view of the locating spike with a rotation guideused for the installation of the locating spike;

FIG. 7 is a perspective view of a drill piercing a hole at a desiredlocation of the femur;

FIG. 8 is an end view of the locating spike inserted into the holecreated in the femur using the rotation guide;

FIG. 9 is a side view of the locating spike being impacted into thefemur using a mallet;

FIG. 10 is a top plan view of the positioning device which is alignedwith a varus-valgus axis;

FIG. 11 is a side elevation view of the positioning device which isaligned with a flexion-extension axis;

FIG. 12 is a perspective view of the tool guide block assembly of FIG.1;

FIG. 13 is a perspective view of the positioning device and the toolguide block assembly assembled together ready for installation;

FIG. 14 is a side view of the universal positioning device assemblybeing installed in place on the locating spike such that the planarsurface of the alignment guide is abutted against the distal end of thefemur;

FIG. 15 is a side view of the universal positioning device assemblymounted on the femur, showing the flexion-extension angle being adjustedand fixed using the lockable handle of the positioning device;

FIG. 16 is a top view of the universal positioning device assemblymounted to the femur, showing adjustment of the varus-valgus angle;

FIG. 17 is top view of the tool guide block assembly and the femur,showing adjustment of the distal resection distance;

FIG. 18 is top view of the tool guide block assembly and the femur,showing the tool guide block being ready for pinning to the anteriorsurface of the femoral condyles;

FIG. 19 is a perspective view of the universal positioning deviceassembly mounted to the femur, showing the disconnection of thepositioning device and the platform of the tool guide block assemblybeing disconnected from the tool guide block which is pinned in place onthe femur;

FIG. 20 is a perspective view of the tool guide block which is leftpinned in place on the femur;

FIG. 21 is a top plan view of two adjacent tool guide blocks showingrelative positions of the cutting guide slot relative to pin holes;

FIG. 22 is a perspective view of the locating spike and associatedextraction adapter;

FIG. 23 is a perspective view of a universal positioning deviceassembly, including a positioning device and a tool guide assembly, inaccordance with another embodiment of the present invention;

FIG. 24 is a schematic side elevation view of a universal positioningdevice assembly in accordance with another embodiment of the presentinvention; and

FIG. 25 is an end elevation view of FIG. 24.

DETAILED DESCRIPTION OF A PREFERRED EMBODIMENT

As seen in FIG. 1, a device 10 for use in orthopedic surgery includesgenerally a positioning device 12 and a tool guide 14 which is mountedthereto. The tool guide 14 includes a platform portion 18 which isengaged to the positioning device 12, and a tool guide block 16 which isreleasably engaged with the platform 18 and is displaceable relativethereto in a controlled manner and in at least one degree of freedom.Preferably, although not necessarily, the platform 18 of the tool guide14 is also releasably engaged to the positioning device 12, i.e. suchthat the platform 18 and the positioning device 12 can be disconnectedfrom each other. However, the tool guide block 16 is necessarilydisengageable from the platform 18 and thus the rest of the device 10.As will be discussed below, the positioning device 12 and the platform18 permit adjustment of the relative position between the tool guideblock 16 and the bone element in multiple degrees of freedom, such thatthe tool guide block 16 can be accurately positioned into a desiredlocation relative to the bone element. As will be described, thepositioning device 12 of the device 10 is removably fastened to the boneelement, such as the femur 11 shown in FIG. 1, using a bone anchor suchas a spike 19.

The device 10 will be described in detail below. The device 10 mayhowever also include certain additional features, or be used in asimilar manner or in accordance with a surgical method, as per thosedevices described in Applicant's own U.S. patent application Ser. Nos.10/357,493, 11/062,737 and 11/042,264, respectively filed on Feb. 4,2003, Feb. 23, 2005 and Jan. 25, 2005, the entire contents of each ofwhich are incorporated herein by reference. These three applicationswere published as US patent application publications nos. 2004/0039396,2005/0203528 and 2006/0195111, respectively.

Throughout this application, the general device 10 described anddepicted herein will be alternately referred to as a device, a universalpositioning device, or universal positioning device assembly, apositioning device assembly or positioning block assembly, and it isunderstood that all of these terms refer to the device 10, which isintended for use in orthopedic surgery, such as for example, total orpartial joint replacement surgery of the knee, elbow, hip, shoulder orother joint, unicondylar osteotomy, unicompartmental knee replacement,total knee arthroplasty, high tibial osteotomy, etc. The present device10 will be described herein with specific reference to its use inorthopedic knee surgery (such as a total knee replacement for example),and more particularly with respect to its use and installation on afemur 11 of a knee joint. However, it is to be understood that thepresent device 10 can be similarly used on a tibia, also during a kneejoint surgery such as a total knee replacement, or alternately still onanother bone element of a patient, such as a bone of an elbow, hip,shoulder or other joint for example.

In the embodiment described herein, the directions of displacement ofthe device 10 will be described with respect to a coordinate systemdefined relative to a femur 11, to which the assembly is installed inthe depicted embodiment. As shown in FIG. 1, this Cartesian coordinatesystem is defined by a Proximate-Distal axis 13, an Anterior-Posterioraxis 15, and a Medial-Lateral axis 17.

Such positioning devices as sometime referred to by those skilled in theart as “positioning blocks” or “universal positioning blocks”, howeverit is to be understood that such devices need not actually include a“block” shaped portion per se. Furthermore, the positioning blockassembly may be used in conjunction with a computer assisted surgical(CAS) system or may be used on its own, i.e. in a standard or non-CASsurgical environment.

The universal positioning device comprises a main positioning device orguide block holder that is operatively engaged, in a releasable manner,with a surgical tool guide block assembly that includes the tool guideblock. The positioning device is adapted to accurately position andalign the tool guide block into a desired location. The surgical toolguide block is adapted for guiding a surgical tool and it is to beunderstood that such a surgical tool as defined herein includes allsurgical instruments necessary for bone surgery and joint replacementsurgery, for example those which can remove bone from a bone element,such as drills, rasps and saws and that such a surgical tool guide blockis similarly adapted for any surgical instrument necessary for jointreplacement surgery, for example those which can remove bone from a boneelement. For example, the tool guide block may be used to guide asurgical saw used to make a resection cut in the bone element and/orused to create a hole therein using a surgical drill. It may be furtherunderstood that the surgical tool guide block may also be a surgicaldevice itself.

As noted above, the universal positioning device assembly may used inconjunction with a CAS system, and thus may be trackable by the CASsystem, which provides means for determining the position, orientationand movement of the universal positioning device assembly in threedimensional space, and permits the universal positioning device assemblyto be visualized, for example using a display, relative to the patientanatomy. The CAS system further provides means for determining a desiredposition of the universal positioning device assembly relative to a boneelement, whether from a real patient, a cadaver or a model. The CASsystem further provides means for indicating where to fasten thesurgical tool guide block on such a bone element such that it can beaffixed into the desired position. Additionally, the present universalpositioning device assembly may be used with both CT-based andimage-less CAS systems or fluoroscopic systems. The CAS system may, inother words, use either computer generated anatomical models createdfrom pre-operatively taken scans, such as CT scans, or useintra-operatively generated bone surface models created by digitizing aplurality of points and anatomic landmarks on the surface of the boneelement, to relate the position of the positioning block assembly to thebone elements of the patient.

Referring to FIGS. 2-3, the positioning device 12 of the universalpositioning device 10 is shown in greater detail. The positioning device12 includes a main block body 20 which has a substantially planarreference surface 22 on one side thereof, namely on a proximally-facingside when the positioning device 12 is being installed onto a distal endof a femur. It is this planar reference surface 22 which abuts thedistal condyle(s) of the femur when the device is installed in place, aswill be described in further detail below. A swing arm member 24 ispivotally engaged to the block body 20 and extends away therefrom in asubstantially distal direction. The swing arm member 24 includes a firstportion 26 and a second portion 28, which pivot together relative to theblock body 20 about a first pivot axis 25, which is adapted to besubstantially parallel to the medial-lateral axis 17 (see FIG. 1) whenthe positioning device 12 is mounted in position on the bone element,such as the femur 11. This is preferably done using a bone anchor in theform of a spike 19 (see FIGS. 1 and 4), which is received through acorrespondingly shaped passage 30 that extends through the length of thesecond portion 28 of the arm member 24. The entire positioning device 12is thus slid onto the spike 19, preferably until the reference surface22 thereof is abutted against the femur 11. The positioning device 12 isfixed in place on the spike 19 by a locking mechanism, including alocking lever 21, which is pivotable between a locked and an unlockedposition. The locking lever 21 is engaged with a friction clamp which isdisposed within the arm member 24 and protrudes into the passage 30therethrough, such as to frictionally engaged the spike 19, therebylocking the positioning device 12 in place at a selected point along thespike. In one embodiment, the spike 19 is provided with a small pin 76thereon, and the arm member 24 includes a correspondingly shaped channel23 in communication with the passage 30, such that when the pin 76 ofthe spike 19 and the channel 23 of the arm member 24 are interlocked,the positioning device 12 is prevented from rotating (i.e. about alongitudinal axis of the spike) on the spike 19. Alternately, of course,the spike could be provided with a non-circular cross-sectional areaand/or shape (such as cross shaped for example), and the passage 30could be similarly shaped, in such case the cooperating pin and channelare no longer required. Also, if preferred by the surgeon such as to beable to manually alter the relative angular orientation of thepositioning device 12 on the spike 12 (i.e. about a longitudinal axis ofthe spike), a spike 19 without such a pin thereon can be used.

The first portion 26 of the swing arm member 24 comprises a lowerplatform portion which can only pivot about the first axis 25 relativeto the block body 20. The second portion 28, which rest on top of thelower platform portion 26, comprises a main arm body, through which thepassage 30 extends. This arm body 28 pivots relative to the block body20 together with the lower platform portion 26 about the first pivotaxis 25, however also pivots in a second, substantially perpendiculardirection, namely about a second pivot axis 27 which is substantiallyparallel to the anterior-posterior axis 15. This is achieved by apivoting joint between the arm body 28 and the lower platform portion26.

Thus, if one were to hold the block body 20 stationary, the entire armmember 24 could be pivotally displaced, about the medial-lateralextending first pivot axis 25, in a first direction 33, which will bedefined herein as a flexion-extension direction or adjustment of theflexion-extension angle, and the arm body portion 28 of the arm member24 would also able to be displaced in a second direction 34, which willbe defined herein as a varus-valgus direction or adjustment of thevarus-valgus angle. However, in use, as it is the arm body portion 28which has the spike passage 30 therethrough, it is this portion of theassembly which remains substantially stationary relative to the femur 11when the positioning device 12 is slid onto the spike 19 in the femur.Thus, when so mounted on the bone spike 19, it is the block body 20which is displaced (relative to the arm body 28 and thus relative to thebone) in the flexion-extension direction 33 and/or the varus-valgusdirection 34. As such, this permits adjustment of flexion-extensionangle and the varus-valgus angle of the block body 20, and therefore ofthe planar reference surface 22 thereof. As will be described, thedisplacement of the block body 20 in these two angular directions iscontrolled using independent adjustment mechanisms.

As noted, relative pivotal movement between the block body 20 and theswing arm 24 about the medial-lateral extending axis 25 is achieved by apivot joint therebetween. Adjustment of this relative flexion-extensionangle is achieved using a lockable adjustment handle 32 (see FIG. 3)which is mounted to the block body 20 and extends therefrom below thepivoting arm member 24. The handle 32 is fixed to the block body 20, andextends through an opening in a projection of the arm member 24 on theplatform portion 26. A rotating locking nut 34 is threadably engaged tothe handle 32, and when tightened, the locking nut 34 is displaced downthe length of the handle 32 towards the block body 20, and acts to clampthe arm member 24 in a fixed pivotal position about the first pivot axis25, relative to the block body 20. This permits the flexion-extensionangle to be fixed at a desired value. Practically, this may be bestachieved by applying a little friction by first lightly tightening thelocking nut 34, permitting the block to be roughly positioned in thedesired flexion-extension orientation. Then, by manipulating the handle32, the finer tuned positioning of the block can be done. Once a finalorientation is reached, the locking nut 34 can be fully tightened to fixthe block in place.

With the arm member 24 fixed in position in the flexion-extensiondirection 33, the block body 20 remains free to be pivotably displacedabout the second pivot axis 27, such as to adjust the varus-valgus anglein direction 34. This is achieved using an adjustment mechanism 36between the platform portion 26 and the arm body 28 of the arm member24, which permits both course and fine adjustment of the varus-valgusangle of the platform portion 26 of the arm member 24, and therefore ofthe block body 20 connected thereto, relative to stationary upper armbody 28 fixed to the spike 19 (and thus fixed relative to the femur 11).

The varus-valgus adjustment mechanism 36 includes a coarse adjustmentmechanism 38 and a fine adjustment mechanism 40. The coarse adjustmentmechanism 38 including a central tab or fork 42 which is cantileveredfrom the remainder of the platform portion 26 at proximal joint 44, suchthat it has a free distal end 43 which can be depressed by a user. Thetab 42 is biased upwards towards the arm body 28 such that a pinion gear50 which is mounted to the tab 42 is normally engaged to a corresponding“rack” (not shown) which is formed on the underside of the arm body 28.Thus, the sprung tab is biased such that the two portions of the armmember 24, namely the arm body 28 and the platform portion 26, areengaged together such as to substantially prevent (unless the fineadjustment mechanism 40 is actuated as will be described below) relativemovement therebetween in the varus-valgus angular direction 40. This isachieved by the engagement of the pinion gear 50 and the associated rack(which make up part of the fine adjustment mechanism 40, which interlockto prevent coarse (or large) relative movement between the two portionsof the arm member 24. However, when the distal end 43 of the sprung tab42 of the platform portion 26 is depressed by a user, the tab 42 ispivoted away from the arm body 28 which thereby disengaged the piniongear 50 from the corresponding rack on the arm body. This accordinglypermits rapid and large (but coarse) relative pivotal movement betweenthe arm body 28 and the platform portion 26 about the second pivot axis27. Thus, the coarse adjustment mechanism 38 enables the user to quicklyand easily position the block body 20 into a rough positioncorresponding to the desired varus-valgus angle between the referencesurface 22 of the block body 20 and the bone element (e.g. the femur).

The fine adjustment mechanism 40 can then be used in order to fine-tunethe exact varus-valgus angle desired. The fine adjustment mechanism 40includes the pinion gear 50 as noted above, the pinion gear 50 beingfixed to a shaft 46 that is rotatably mounted to the tab 42 of theplatform portion 26. At each opposed end of the shaft 46 is provided ascrew knob 48. Accordingly, by rotating the screw knobs 38 in eitherdirection, pinion gear 50 (which is in engagement with the rack giventhe coarse adjustment mechanism 38 is no longer actuated) is displacedrelative to the fixed rack on the arm body 28 in the direction 34,thereby displacing the platform portion 26 in relatively smallincrements in this direction, thereby permitting the exact value of thevarus-valgus angle to be adjusted.

Although the adjustment mechanism 36, which includes the integratedcoarse adjustment mechanism 38 and the fine adjustment mechanism 40, hasbeen described above particularly with its use for adjusting thevarus-valgus angle of the device, it is also to be understood that thepositioning device 12 can be configured such that this type of coarseand fine adjustment mechanism 36 can also be provided for the adjustmentof the flexion-extension angle in stead of the simpler pivotingadjustment described above, and this either in addition to or instead ofthe adjustment mechanism 36 used for the varus-valgus angle adjustment.

Now that the positioning device 12 of the universal positioning device10 has been described, the other portion of the assembly, namely thetool guide 14, will now be discussed. Referring to FIG. 1 and FIG. 5,the tool guide 14 includes generally a platform 18 and a tool guideblock 16 mounted thereto. The tool guide block 16 is that which is usedby the surgeon to create a cut, a hole, etc in the bone element beingoperated on, such as the femur described herein. The tool guide block 16thus may include one or more of a cutting guide slot, a drilling guidehole, pin guide holes and the like, or any combination thereof. In oneexample, the tool guide block 16 is used to make a resection cut in adistal end of a femur, such as during a knee replacement surgery.Typically, and as will be described further below, once the guide block16 is located in a desired position on the femur 11 with the aid of thepositioning device 12, holes are then drilled into the bone using theguide holes 51 in the guide block 16 and pins 54 (see FIG. 1 forexample) are inserted therethrough such as to pin the guide block 16 tothe femur in this desired location. A resection cut can then be made atthe desired location and angle in the femur, using for example a sawblade guide slot 52 located in the guide block 16.

The platform 18 includes two downwardly extending legs 56, which arereceived within two correspondingly shaped openings 58 defined in theblock body 20 of the positioning device 12 (see FIGS. 2-3). Thus, theplatform 18 is removably engaged to the block body 20 of the positioningdevice 12 by inserting the legs 56 into the openings 58, and thensliding the platform down into abutting engagement with an anteriorsurface 55 on the proximal end of the positioning device. The platform18 includes a threaded adjustment mechanism 60, which includes arotating adjustment knob 62 which actuates the threaded shaft 64 of themechanism to rotate, thereby rotating the captive shaft 64 and thustranslating the tool guide block 16, which is engaged to a free end 66of the shaft 64, in a proximal-distal direction 70. The adjustmentmechanism 60 thus provides for adjustment of a distal resection distancein a total knee replacement operation (i.e. the distance in a proximaldirection away from the distal most point on the femoral condyles—towhich the reference surface 22 of the block body 20 is abutted—which isdesired such that the distal resection cut to be made in the femur islocated in a desired position).

As noted above, the platform 18 is disengageable from the tool guideblock 16, such that once the tool guide block 16 is located in a desiredlocation relative to the bone element, it can be pinned in place theretoand the platform 18 (and accordingly the rest of the universalpositioning device assembly 10) can be unfastened from the tool guideblock 16 and removed from engagement with the bone. Accordingly, byunscrewing the un-coupling knob 68, the threaded shaft 64 is disengagedand withdrawn from the threaded aperture 72 in the guide block 16 towhich it was received.

As best seen in FIG. 5, the tool guide block 16 includes severaldifferent apertures 72 therein with which the free end 66 of thethreaded shaft 64 can be matingly engaged. More particularly, in thedepicted embodiment, three such apertures 72 are provided, namely onecentrally located aperture and one aperture located on each of theopposed lateral ends of the substantially elongated tool guide block 16.This provides an improved range of possible locations of the tool guideblock 16 relative to the bone to which is being positioned. For example,when on a femur 11 in a knee replacement surgery, this permits anincreased number of resection cuts to be possible using the presentassembly, such as both from an anterior direction and from either a moremedial or lateral direction. This provides improved flexibility ofpositioning of the tool guide block 16, relative to many prior artstructures for example which only permit engagement of a tool guideblock at a single, typically, central location thereto.

Having generally described the structure of the universal positioningdevice assembly 10, a method of use thereof will now be described withreference to performing a distal resection cut in a femur during a totalknee replacement surgery. The steps performed in accordance with thismethod are those for positioning the tool guide block in preparation ofperforming a distal cut in the femur in accordance with a so-called“distal cut first” surgical procedure, however as noted above it is tobe understood that the universal positioning device assembly 10 can alsobe used with the alternate “anterior cut first” procedure of preparingthe femur for the installation of a femoral implant in a kneereplacement surgery.

Reference will now be made to FIGS. 6-22 which depict the successivesteps employed in using the universal positioning device assembly 10 forpositioning the tool guide block 16 on the femur in preparation ofmaking a distal resection cut in a femur 11 in preparation for the femurreceiving an implant as part of a total knee replacement surgicalprocedure.

FIG. 6 shows a first step of sliding a rotation guide 74 onto a distalend of a spike 19, such as that described above and shown in FIG. 4. Thespike 19 acts as a bone anchor and includes, as best seen in FIG. 4, asharp and pointed proximal end 71 for being driven into the femur 11, asubstantially smooth cylindrical body 73 and a distal end 75 with agroove 77 therein. As seen in FIG. 6, the rotation guide 74 is slid ontothe distal end 75 of the spike 19, such that the small pin 76 (whichradially projects from the surface of the spike's body 73) is receivedwithin a correspondingly shaped channel 77 formed along the length ofthe rotation guide 74, thus preventing relative rotation between thespike 19 and the rotation guide 74.

As shown in FIG. 7, the bone cortex is then broken at the distal end ofthe femur 11, using a drill bit 78 for example, or alternately a cortexbreaker. This hole in the femur 11 is created at the exit point of themechanical axis of the femur.

FIG. 8 shows the next step, which is to align the two laterallyprojecting guide arms 79 of the rotation guide 74 such that they aresubstantially parallel with the femoral posterior axis 80, i.e. an axispassing through the two most posterior points of the femoral condyles.

The next step, shown in FIG. 9, is to insert the shaft proximal end 71of the spike 19 into the hole created in the distal end of the femur 11,with the laterally projecting guide arms 79 still in alignment with thefemoral posterior axis. The spike 19 can then be impacted into the femura desired distance, using an impact mallet 81 for example. The spikeshould be securely embedded into the femur 11 such that no play exists,however should only be impacted to a maximum depth which is marked onthe spike 19. This may correspond to the length of the four cross-shapedblades of the sharp proximal end 71 of the spike 19.

Referring now to FIGS. 10 and 11, the positioning device 12 as describedabove is then preferably pre-aligned in a neutral position, such as tosave the surgeon time with subsequently making the femoral adjustments.This is done by aligning the varus-valgus angle, i.e. between thereference surface 22 of the block body 20 and the arm member 24, at 0degrees as shown in FIG. 10, such as by using the coarse adjustmentmechanism 38 in the manner described above. The flexion-extension anglebetween the reference surface 22 of the block body 20 and the arm member24 is also then pre-aligned at 0 degrees, as shown in FIG. 11, such asby using the adjustment handle 32 and associated locking nut 34 in themanner described above. In preparation of being mounted to the spike,the locking lever 21 is also preferably rotated into its unlockedposition, as depicted in FIG. 10.

As shown in FIG. 12, if it has not already been done, the tool guideblock 16 is engaged to the platform 18, such as to assembly the toolguide 14. Any one of the various apertures 72 in the guide block 16 maybe used for mating engagement with the threaded shaft 64, howevertypically the central one is first chosen, as shown in FIG. 12.

The now assembled tool guide 14 can then be mounted onto the positioningdevice 12, in a manner described above, such as to arrive at thecomplete device 10. The fully assembled universal positioning device 10is shown in FIG. 13.

As seen in FIG. 14, the universal positioning device 10 is then slidonto the spike 19, by inserting the distal end 75 of the spike 19 intothe passage 30 defined in the arm body 28 of the positioning device 12,as described above. Care should be taken to align the anti-rotation pin76 of the spike with the channel 23 defined in the arm body 28 of thepositioning device 10, as noted above, in order to prevent unwantedrotation of the entire assembly 10 about the longitudinal axis of thespike 19. The universal positioning device assembly 10 is slid fullydown the spike 19 in the proximal direction 82, until the planarreference surface 22 of the block body 20 directly abuts the distal mostpoint on either of the condyles of the femur. Once in place, the lockinglever 21 may, if desired, be moved into its locked position such as tolocate the positioning device in place (in the proximal-distaldirection) on the spike 19.

The adjustment of the flexion-extension angle and the varus-valgus angleis now performed, such to achieve the desired values thereof which maybe provided by, or determined with the aid of, a CAS system. The desiredvalues of these angles will correspond to those which will result in adesired final position and orientation of the tool guide block 16, suchas to permit a distal resection cut in the desired location andorientation.

As seen in FIG. 15, the flexion-extension angle is preferably firstadjusted, using the adjustment handle 32 described above. For example,the handle 32 is manipulated in the direction 33, with a slight frictionapplied by the locking nut 34, such as to pivot the block body 20 (andtherefore the tool guide assembly 14 mounted thereto) about the pivotaxis 25, thereby varying the flexion-extension angle thereof, in themanner described in more detail above. Once in the final positioncorresponding to the desired flexion-extension angle, the locking nut 34is rotated as shown to lock the device in this angular position.

As shown in FIG. 16, the varus-valgus adjustment is then performed, inthe manner described above, using the adjustment mechanism 36 of thepositioning device 12. Generally, coarse adjustment of the varus-valgusangle is made by depressing the tab 42 and sliding the platform portion26 in the direction 34 relative to the stationary arm body 28 fixed tothe spike 19. Once the desired location is reached, releasing the tab 42will cause the rack and pinion mechanism of the fine adjustmentmechanism 40 to re-engage. The rack and pinion mechanism may beconfigured such that pre-defined increments of known amounts (ex: 1degree steps) can be felt by the user when displacing the platformportion 26 during the coarse adjustment. Fine tuning of the exactvarus-valgus angle (ex: for values between full degree steps) can thenbe performed by rotating the screw knobs 48 which rotate the captivepinion gear, thereby displacing the platform portion 26 relative to thearm body 28 in smaller increments in the varus-valgus direction 34.Visual markers on either of the platform portion 26 and the arm body 28can be provided so as to indicate the angular varus-valgus position awayfrom the 0 degree. Alternately, the CAS system may be used to providethis indication.

Referring now to FIG. 17, the next step performed is to adjust theproximal-distal positioning of the tool guide block 16, and thereforethe distance in the proximal direction of the guide block 16 away fromthe reference surface 22 of the block body 20, which defines a plane inwhich lies the distal most point on the femur 11. This position of theguide block 16 is selected such as to locate the cutting guide slot 52defined in the tool guide block 16 at a given position corresponding tothe desired distal resection distance. This distal resection distanceadjustment is done by rotating the adjustment knob 62 on the platform 18of the tool guide block assembly 14, thereby translating the tool guideblock 16 inward or outward relative to the platform 14 in theproximal-distal direction 70. Indicators 84 are provided on the shaft64, such as to easily be able to determine the distal resection distanceas the tool guide block 16 is displaced proximally in direction 70.

Once the desired distal resection distance has been reached, the toolguide block 16 is pinned in place to the femur 11. First, however, oneshould make sure that the reference surface 22 of the positioning device12 remains securely abutted against the distal-most condyle of the femur11 (i.e. the “reference distal condyle”), as shown in FIG. 18. The toolguide block 16 can then be pinned in place using the first or “0” set ofholes 51 defined through the tool guide block 16, best seen in FIG. 18.This may be done by first drilling holes in the bone using these firstset of block holes 51 as drill guides, and then inserting the bone pins54 through these block holes 51 and into the femur 11, such that thetool guide block 16 is securely pinned in place to the anterior surfaceof the femur 11 as shown in FIG. 19.

The rest of the universal positioning device 10 can then be disengagedfrom the tool guide block 16, which is now securely pinned to the femur11, by unscrewing the un-coupling knob 68 on the platform 18 of the toolguide 14, in the manner described above. Once the un-coupling knob 68has been sufficiently turned so that the tool guide block assembly 14and the positioning device 12 are disconnected from the pinned guideblock 16, the entire assembly 10 can then be completely removed bysliding it off the spike 19 in the femur 11. This therefore leavesbehind only the tool guide block 16, as shown in FIG. 20, which is nowpinned to the femur 11 using pins 54 in a desired position andorientation which permits the distal resection cut to be performed usingthe saw guide slot 52 in the tool guide block 16 at a predeterminedlocation and angle in femur 11.

FIG. 21 depicts two tool guide blocks 16 adjacent to each other, howeverthis is done for explanation purposed only. Particularly, once the toolguide block 16 is pinned to the femur using the pins 54, which wereinserted through the first set of “0” holes 51 in the guide block, itmay sometimes become necessary to remove a different amount of bone.Thus, a larger or smaller resection distance than that which wasoriginally calculated or planned for may become necessary. In order topermit this, without having to re-perform the entire procedure describedabove, additional sets of pin holes are provided in the guide block 16at specific locations corresponding to measured increments over theinitial “0” value. Thus, if it becomes desirable or necessary to resectand additional 4 mm of bone for example, the guide block 16 can simplybe slide up and off the pins 54 which remain pinned to the femur, andthen re-positioned on the pins 54 but using an alternate set of holes86, which are labelled on the block as “+4”, as shown on the right inFIG. 21. As the holes 86 are defined an exact 4 mm distance from thefirst set of “0” holes 51, and the pins 54 have remained at the sameangle relative to the femur 11, no further repositioning is required toremove an additional 4 mm of bone. A number of such additional sets ofholes may be provided in the tool guide block 16, such as to permit −2mm, +2 mm, +4 mm and +6 mm for example.

Once the tool guide block 16 is fully pinned in place on the femur, thelocating spike 19 can be removed. This may be done in a variety ofmanners, for example using an extraction adapter 88 as shown in FIG. 22.Particularly, the extraction adapter 88 is placed onto the distal end 75of the spike 19, and engages the annular channel 77 formed therein. Theextraction adapter 88 may be opened for engagement onto the spike 19 bysliding a sleeve 90 thereon in the longitudinal direction 92 indicated.Once on place on the distal end 75 of the spike, the biased sleeve isreleased, causing the extraction adapter 88 to lock into engagement withthe annular channel 77 on the spike's distal end 75. Once so engaged, astandard “slap hammer” may be used to engage the extraction adapter 88and force the spike 19 out of the femur 19. Other means of extractingthe spike 19 from the femur may also be used, either with or without theextraction adapter 88.

Referring now to FIGS. 23-25, a universal positioning device 110 inaccordance with an alternate embodiment is depicted. One of theprinciple differences between this positioning device 110 and theuniversal positioning device 10 described above is that in thisembodiment, the positioning device portion 112 is not fastened to thefemur 11 using the spike described above or any other type of boneanchor. As such, the positioning device 110 is intended to be used withan alternate “freehand” guide positioning approach for the femoralpreparation in a total knee replacement. While this technique may beslightly less accurate than that described above, wherein the entireguide block assembly is fastened to the femur such as to be able toprecisely position the tool guide block, the advantage of this“freehand” option is that it is much less invasive for the patient (infact it is not invasive at all), given that no bone anchor needs to befastened to the femur. However, the challenge for such a non-fastenedpositioning guide is to provide enough stability to keep the tool guideblock in a relatively stable position until such time as it ispositioned in a desired orientation and pinned in place on the femur.

Accordingly, the universal positioning device 110 includes no boneanchor, and as such is never fastened to the bone while neverthelessstill permitting relatively controlled and independent adjustment of thevarus-valgus, flexion-extension and distal resection depth values. Theuniversal positioning device assembly 110 includes a positioning device112, which lacks any sort of mounting point for a spike or intermedularrod, and a tool guide 114 mounted thereto. The tool guide block assembly114 is as per the tool guide 14 described above, with the exception ofthe mounting structure of the platform 118 to permit it to be releasablyengaged to the positioning device 112. Thus, the tool guide 114 includesthe tool guide block 116 mounted to platform 118 via a proximal-distaladjustment mechanism 160 that permits controlled adjustment of thedistal resection depth by rotating the adjustment knob 162. Alsosimilarly, the remainder of the entire device 110 can be disconnectedfrom the tool guide block 116 once it is pinned in position byunscrewing the un-coupling knob 168. It is the positioning device 112which is largely different from that of the universal positioning device10 described above.

The positioning device 112 includes simply a substantially planar body120 which includes an inner (or proximally facing) reference surface 122that is adapted to overly and abut the distal end of the femoralcondyles. Medial-lateral adjustment is provided by two spaced apartjack-screws 135, one on the medial side of the body 120 and the other onthe lateral side thereof. The proximal ends of these medial-lateraladjustment jack-screws 135 act against the distal end of the femur whenrotated, such as to permit adjustment of the varus-valgus positioningangle of the guide block 116. Although the remaining adjustment (i.e. ofthe flexion-extension angle) direction is not controlled by anadjustment mechanism, relatively controlled variation of this angle canbe achieved by carefully “rolling” the entire assembly on the distal endof the femur 11, keeping the inner surface of the planar body 120 incontact with the femur, such as to align the positioning device in aposition corresponding to a desired flexion-extension angle. Given thatthe positioning device 112 is already fairly stable, as it is in matedcontact with several points on the condyles of the femur 11, namely theinner surface 122 of the body 120 on positioning device 112 which isabutted against the distal points on the condyles and the tool guideblock 116 itself which is abutted on the anterior surfaces of thecondyles. These two separate points of contact between the universalpositioning device 110 and the femur 11 permit a relatively secure orsemi-stable position, despite the positioning device not being fastenedto the femur.

These adjustments may be performed using a tracker of an associated CASsystem, the tracker being removably mounted to the tool guide block16/116, such that the CAS system can indicate when the desired positionand orientation of the tool guide block 16 is reached. Alternately, thetracker of the CAS system can be mounted to the positioning deviceportion of the assembly.

Once the tool guide block 116 is located in the desired position andorientation (i.e. the flexion-extension and varus-valgus angles and thedistal resection depth have been adjusted and selected as described),the tool guide block 116 can be pinned in place to the anterior side ofthe femoral condyles, as described in the method above. Preferably,however, when pinning the tool guide block 116 to the femur, the firstpin is inserted through the selected hole in the tool guide block 116 onthe side of the femur which corresponds to the reference condyle (i.e.that condyle which is the most distal and thus which is used as thereference point throughout). This first pin therefore fixes theflexion-extension angle as well as the distal resection depth, at leaston this reference condyle. The tool guide block 116 can then be slightlypivoted about the first pin, such as to permit the fine tuning of thevarus-valgus angle if this should be necessary. As the first pin islocated on the reference condyle, rotating the tool guide block 116about this pivot point (i.e. the first pin) does not significantlychange the resection thickness measure. Once the desired varus-valgusangle is reached, the second pin can then be installed through the toolguide block 116, thereby fixing it in place for the distal resectioncut.

In the embodiment of FIG. 24-25, a universal positioning device assembly210 in accordance with another embodiment is shown. This assembly ismuch as per the universal positioning device 110 shown in FIG. 23 anddescribed above, therefore including both a proximal-distal adjustmentmechanism 260 on the tool guide 214 to vary the distal resection depthand two jack-screws 235 on the body 220 of the positioning device 212 tovary the varus-valgus angle. However in this embodiment, the body 220 ofthe positioning device 212 includes posterior forks 131 which extendaway from the planar body 22 and are substantially perpendicularthereto. As such, when the inner surface 222 of the planar body 220 isabutted against a distal end of the femur 11, the posterior forks 231extend proximally and on the posterior side of the femur. Thus, with theposterior forks 231 abutted against the posterior surfaces of thecondyles, and additional point of contact between the assembly and thefemur is provided, thereby potentially further improving the stabilityof the assembly during positioning of the tool guide block 216.

However, given that the universal positioning device 210 includes bothanterior (i.e. the tool guide block 216) and posterior (i.e. theposterior forks 231) abutment points, adjustment of the device isdesirable in this anterior-posterior direction such as to be able toaccommodate a variety of different knee sizes. As such, the universalpositioning device 210 also includes an anterior-posterior adjustmentmechanism 237 which permits the controlled displacement of the body 220of the positioning device 212 and the platform portion 218 of the toolguide 214 towards and/or away from each other in the anterior-posteriordirection 215. Thus, the two abutment portions, namely the posteriorforks 231 and the tool guide block 216, can be displaced relative toeach other in the anterior-posterior direction 215 such as to be able toaccommodate a variety of sizes of femurs 11. Another advantage of thisconfiguration is that rotation of the entire assembly about the femurwould then be fixed by the posterior condyles, thus ensuring that byrotating the jack-screws 235 adjusts only the varus-valgus angle anddoes not impart any flexion component to the displacement of the toolguide block. When used in conjunction with a CAS system, this may alsopermit the elimination of an otherwise typically employed step ofdigitizing the posterior condyles, as this can now be done directly withthe positioning device 212 of the universal positioning device 210(given that the posterior forks 231 abut the posterior condyles),provided a CAS tracker is fixed to a portion of the assembly.

The use of the universal positioning device 110/210 has the addedadvantage of saving time by removing the necessity of installing andthen subsequently removing the spike or an intermedular rod, andpotentially removing the need to separately digitize the posteriorcondyles or the distal condyles for a desired resection level, thussimplifying and speeding-up the entire procedure. The other majoradvantage of the use of either of these assemblies is that they arenon-invasive to the patient, given that no bone anchor needs (ex: spike,etc.) to be inserted into the femur.

Although the universal positioning devices 10, 110, 210 have beendepicted and described above generally without reference to a CAStracker which is fastened (temporarily or permanently) thereto, it is tobe understood that the devices described herein are able to be used ineither a standard surgical procedure (i.e. non-CAS) or used inconjunction with a CAS system. As such, the universal positioning device10, 110, 210 may be provided with a CAS tracker when used with a CASsystem. Such trackers are well known in the art, and typically comprisesat least three detectable elements, engaged to the tracker member, whichare detected by the CAS system and permit the CAS system to determinethe exact position and orientation in three dimensional space of thetracker, and accordingly of the device to which the tracker is fixed.The tracker may be removably mounted to a portion of the universalpositioning device 10, 110, 210. For example, the tracker may be mountedto the tool guide block 16, 116, 216, such as by engaging the saw guideslot 52 therein for example. The detectable elements may be, forexample, spherical passive markers locatable by a camera-based, opticaltracking CAS system. However, it is to be understood that active opticalmarkers may equivalently be used as the detectable elements and that CASsystems using any other type of tracking elements, such as for exampleelectromagnetically and acoustically detectable elements, may alsosimilarly be employed. The tracker member thus permits the CAS system totrack the precise position of the expected cutting plane of the surgicaltool guide block 16. However, the present 10, 110, 210 can equivalentlybe used in conventional, or non-computer assisted, surgicalapplications.

The embodiments of the invention described above are intended to beexemplary. Those skilled in the art will therefore appreciate that theforgoing description is illustrative only, and that various alternativesand modifications can be devised without departing from the spirit ofthe present invention. Accordingly, the present is intended to embraceall such alternatives, modifications and variances which fall within thescope of the appended claims.

The invention claimed is:
 1. A method of installing a tool guide blockon a knee bone element in preparation of a cut to be performed in theknee bone element during orthopedic knee replacement surgery, the toolguide block being engaged to a positioning device, the methodcomprising: abutting a first reference surface of the positioning deviceagainst the knee bone element; determining a desired position andorientation of the tool guide block relative to the knee bone element;adjusting at least one of a positioning and orientation of thepositioning device until the tool guide block engaged thereto is in saiddesired position and orientation, the step of adjusting comprising:adjusting a flexion-extension angle of the tool guide block whilemaintaining the first reference surface abutted against the knee boneelement; independently adjusting a varus-valgus angle of the tool guideblock by first making a coarse adjustment and then making a fineadjustment using a varus-valgus adjustment mechanism disposed on thepositioning device, the varus-valgus adjustment mechanism including botha coarse adjustment mechanism permitting coarse adjustment of thevarus-valgus angle and a fine adjustment mechanism permitting fineadjustment of the varus-valgus angle, the step of adjusting thevarus-valgus angle including first making the coarse adjustment usingthe coarse adjustment mechanism and then making a fine adjustmentthereof using the fine adjustment mechanism; adjusting a distalresection depth by displacing the tool guide block relative to thepositioning device; locking the positioning device in position such asto maintain the adjusted flexion-extension angle, varus-valgus angle,and distal resection depth of the tool guide block; and fastening thetool guide block in place to the knee bone element once the desiredposition and orientation of the tool guide block has been reached. 2.The method as defined in claim 1, wherein the step of adjusting theflexion-extension angle of the tool guide block includes using aflexion-extension adjustment mechanism disposed on the positioningdevice.
 3. The method as defined in claim 1, further comprisingfastening the positioning device to the knee bone element using a boneanchor.
 4. The method as defined in claim 3, further comprisingfastening the bone anchor to the knee bone element and the removablyengaging the positioning device to the bone anchor.
 5. The method asdefined in claim 4, wherein the bone anchor includes an anti-rotationelement thereon which is receivable within a corresponding opening inthe positioning device, the step of fastening the bone anchor to theknee bone element including using a rotation guide to align the boneanchor in a desired orientation about a longitudinal axis of the boneanchor.
 6. The method as defined in claim 1, further comprisingdisconnecting the positioning block from the tool guide block followingthe step of fastening the tool guide block in place to the knee boneelement.
 7. The method as defined in claim 1, wherein the step ofadjusting the distal resection depth includes using a proximal-distaladjustment mechanism disposed between the tool guide block and thepositioning device, in order to displace the tool guide block relativeto the first reference surface of the positioning device in a directionsubstantially parallel to a proximal-distal axis relative to the kneebone element.
 8. The method as defined in claim 1, further comprisingabutting a second reference surface of the positioning device againstanother portion of the knee bone element, the first and second referencesurfaces being substantially perpendicular to each other.
 9. The methodas defined in claim 1, further comprising using a computer assistedsurgery (CAS) system, communicable with at least the tool guide block,to determine the desired position and orientation of the tool guideblock relative to the knee bone element.
 10. The method as defined inclaim 9, further comprising using the CAS system to determine when thetool guide block has reached said desired position and orientation. 11.The method as defined in claim 9, further comprising using the CASsystem to display the desired position and orientation of the tool guideblock and an actual position and orientation of the tool guide block.